Effect of Photobiomodulation as a Preventive Treatment for Diabetic Foot: Randomized Controlled Blinded Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Ulcer Incidence
研究概览
简要总结
This study seeks to evaluate the effect of photobiomodulation (PBM) in the prevention of Diabetic foot (DF), in patients at moderate and high risk for its development, through a controlled, randomized, double-blind clinical trial. Individuals between 18 and 75 years old of both sexes, with type 2 diabetes mellitus (DM), and moderate and high risk for DF will be randomized and allocated into 2 groups of 32 participants each. The PBM Group will use a boot with 1344 LEDs, 504 of which are 660 nm located on the sides of the boot (28.5 milliwatt, 10 J per LED); 504 850 nm also located on the sides of the boot (23 milliwatt, 8 J per LED); 168 of 660 nm located at the base of the boot (28.5 milliwatt, 10 J per LED); 168 of 850 nm also located at the base of the boot (23 milliwatt, 8 J per LED) once a day for 6 minutes, for 60 days and will receive therapeutic education. Participants will be evaluated at baseline, after 30 days (clinical examination) and after 60 days (clinical examination, Peripheral Neuropathy (PN) assessment, Peripheral Artery Disease (PAD) assessment, blood and urine tests, and quality of life).
详细描述
Diabetic foot (DF) prevention involves risk classification, systemic care, assessment of Peripheral Artery Disease (PAD) and Peripheral Neuropathy (PN), regular foot examination, therapeutic education, and routine use of appropriate footwear. Photobiomodulation (PBM) has been successfully applied in the healing of DF. In addition to the therapeutic effects of PBM, its preventive effects have attracted the attention of researchers. This study seeks to evaluate the effect of PBM in the prevention of DF, in patients at moderate and high risk for its development, through a controlled, randomized, double-blind clinical trial. Individuals between 18 and 75 years old of both sexes, with type 2 DM, and moderate and high risk for DF will be randomized and allocated into 2 groups of 32 participants each. The PBM Group will use a boot with 1344 LEDs, 504 of which are 660 nm located on the sides of the boot (28.5 milliwatt, 10 J per LED); 504 850 nm also located on the sides of the boot (23 milliwatt, 8 J per LED); 168 of 660 nm located at the base of the boot (28.5 milliwatt, 10 J per LED); 168 of 850 nm also located at the base of the boot (23 milliwatt, 8 J per LED) once a day for 6 minutes, for 60 days and will receive therapeutic education. Participants will be evaluated at baseline and after 30 days (clinical examination) and 60 days (clinical examination, PN assessment, PAD assessment, blood and urine tests, and quality of life). The collected data will be stored, and organized in a repository and the appropriate statistical tests will be applied for each specific analysis. In all tests, a significance level of 5% will be adopted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
- 1 physician-researcher who will conduct all initial evaluations and follow-up examinations (excluding Doppler ultrasound, Ankle-Brachial Index - ABI, and Toe-Brachial Index - TBI), without knowledge of the subjects' allocation, and will administer the Informed Consent Form (ICF).
- 1 Vascular surgeon researcher who will perform Doppler ultrasound, Ankle-Brachial Index (ABI), and Toe-Brachial Index (TBI) measurements during the initial assessment and follow-up examinations, without knowledge of the subjects' allocation.
- 1 Nurse researcher who will retrieve the allocation envelope and provide the appropriate PBM equipment (active or placebo), as well as provide recommendations for its use at home.
- 1 Researcher, who will not participate in any assessments, will prepare randomization and envelopes to ensure allocation confidentiality.
- 2 physician residents who will provide daily contact for device usage control, guidance, addressing inquiries, etc.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals diagnosed with type 2 Diabetes Mellitus (according to American Diabetes Association 2021 criteria),
- •both sexes,
- •between 18 and 75 years,
- •Individuals classified, according to the International Working Group on the Diabetic Foot (IWGDF- 2019) scale, as moderate to high risk for developing diabetic foot,
排除标准
- •Pregnant women
- •Individuals diagnosed with type 1 diabetics,
- •Individuals with neuropathy secondary to uncontrolled conditions (hypothyroidism, vitamin B12 deficiency, alcoholism),
- •Individuals diagnosed with active infectious condition at the time of inclusion,
- •Individuals diagnosed with active ulcer or infectious skin lesion on the legs/feet,
- •Individuals with historic of osteomyelitis,
- •Individuals with Parkinson's disease,
- •Individuals with contracture condition,
- •Individuals with severe lower limb ischemia (Fontaine III and IV - Rutherford 4 to 6),
- •Individuals with a suspicious skin lesion for neoplasms or cutaneous dysplasias on the legs/feet
- •Individuals diagnosed with oncologic disease or undergoing treatment within the last 3 (three) months,
- •Individuals presenting unstable angina, recent acute myocardial infarction, history of severe arrhythmia within the last six months,
- •Individuals diagnosed with decompensated Chronic Obstructive Pulmonary Disease (COPD),
- •Inability to understand the ICF,
- •Inability to attend appointments regularly.
结局指标
主要结局
Ulcer Incidence
时间窗: at 60 days
The incidence of foot ulcers will be assessed through clinical examination. In addition to these in-person assessments, participants will be monitored daily via telephone contact, during which the researchers (resident physicians) will inquire about any changes in the skin, discomfort, and the use of PBM equipment.
次要结局
- Neuropathy Symptom Score (NSS)(at 60 days)
- Assessment of Achilles reflex(at 60 days)
- Resistance Index(at 60 days)
- Waveform pattern(at 60 days)
- Vibratory sensitivity(at 60 days)
- Systolic peak velocity(at 60 days)
- Tactile sensitivity with Semmes-Weinstein monofilament(at 60 days)
- Evaluation of claudication(at 60 days)
- Neuropathic Impairment Score (NIS)(at 60 days)
- Evaluation of the degree of ischemia(at 60 days)
- Thermography(at 60 days)
- Quality of Life Assessment(at 60 days)
研究者
Kristianne Porta Santos Fernandes
Principal Investigator
University of Nove de Julho